Trial document




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  DRKS00016859

Trial Description

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Title

Mobilization in the EveNing to prevent and TreAt deLirium

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Trial Acronym

MENTAL

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URL of the Trial

http://-

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Brief Summary in Lay Language

Patients in intensive care units are at high risk for delirium. A delirium is characterized by a disturbance of thinking, changing course and disturbance of the day and night rhythm. Mobilization in the evening could help patients to avoid or shorten their delirium. In a randomized study, it should be found out whether an evening mobilization can actually help in comparison to the usual care.

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Brief Summary in Scientific Language

Background: Delirium in ICU patients is common and increases complication rate, duration of mechanically ventilation and length of stay, and mortality. Non-pharmacological interventions such as early mobilization can shorten the duration of an already existing delirium or preventively reduce the incidence of delirium.
Problem: Early mobilization as delirium prophylaxis and therapy is so far recommended only during the day to allow patients a night's rest. However, many patients with delirium or delirium risk have a disturbed daytime nightmare with increased daytime sleep and reduced sleep periods.
Hypothesis: intensive care unit patients who a) have a Richmond Agitation Sedation Score (RASS) ≥ -3 and are responsive, b) are susceptible to delirium, and c) are mobilizable, performing gradual mobilization out of bed bed between 21:00 and 23:00, compared to patients who are treated by usual care, have a shorter duration of delirium.
Method: Multicentre, randomized, controlled study on 4 mixed intensive care units in 2 centers over a period of 2 weeks with max. 28 days follow-up. Patients will be mobilized onto the edge of the bed or more between 21:00 and 23:00, according to safety criteria. This intervention is carried out by additional mobilization teams consisting of nurses and physiotherapists or others. The primary outcome parameter is the duration of a delirium. Secondary outcome parameters are the feasibility, presence of delirium, mortality, duration of mechanically ventilation and stay, mobilization (time, duration, stage), mobilization-related complications, dependency at discharge, costs.
Expected Result: The study will provide isights as to whether evening bedside mobilization may shorten or avoid delirium in patients and influence other parameters. In addition, it is possible to estimate the effect of additional staff.

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Organizational Data

  •   DRKS00016859
  •   2019/02/26
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  •   yes
  •   Approved
  •   D408/19, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

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Health Condition or Problem studied

  •   F05 -  Delirium, not induced by alcohol and other psychoactive substances
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Interventions/Observational Groups

  •   INTERVENTION
    The intervention will be conducted by a mobility-team between 9.00 and 11.00 p.m.
    The intervention begins on day 1, or after consent and randomization. The duration of the intervention will last for min. 3 minutes till max. 120 minutes. The intervention will be conducted on three consecutive evenings.
  •   Patients in the control group receive the usual care and are mobilized during the day by physiotherapists and nurses. If necessary, they will receive the same pharmacological treatment as patients in the intervention group.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Duration of delirium. Patients will be assessed for delirium three times in 24h using the Confusion Assessment Method for the Intensive Care Unit

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Secondary Outcome

Following data will be extracted from patients charts
Presence of delirium, assessed 3x/24h by Confusion Assessment Method for the Intensive Care Unit
Mortality
Duration of mechanically ventilation in days
Length of stay in days
Mobilisations (time, duration, level)
Mobility-related complications
Independency assessed by Barthel-Index
Costs by Diagnosis Related Groups

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Countries of Recruitment

  •   Germany
  •   United Kingdom
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/06/03
  •   68
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

a) age ≥18 years, B) Richmond Agitation Sedation Scale ≥ -3 (respond to command), c) are susceptible to delirium, d) are mobilizable, e) expected min. one night in intensive care

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Exclusion Criteria

a) condition with the expectation of death in the next 72h, b) No approval of the study, c) Rejection of evening mobilization, d) Pre-existing immobility, e) Contraindication to mobilization

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinikum Schleswig-Holstein, Pflegeforschung, Campus Kiel
    • Mr.  Peter  Nydahl 
    • Brunswiker Str. 10
    • 24105  Kiel
    • Germany
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    • Universitätsklinikum Schleswig-Holstein, Klinik für Anästhesiologie und operative Intensivmedizin
    • Mr.  Dr.  Matthias  Kott 
    • Schittenhelmstr. 10
    • 24105  Kiel
    • Germany
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    • Universitätsklinikum Schleswig-Holstein, Klinik für Anästhesiologie und operative Intensivmedizin
    • Mr.  Dr.  Norbert  Weiler 
    • Schittenhelmstr. 10
    • 24105  Kiel
    • Germany
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    • Universitätsklinikum Schleswig-Holstein, Institut für medizinische Informatik und Statistik
    • Mr.  Dr.  Christoph  Borzikowsky 
    • Schittenhelmstr. 10
    • 24105  Kiel
    • Germany
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    • Abteilung für Anästhesiologie, Universitätsklinikum Heidelberg
    • Ms.  Dr.  Rebecca  von Haken 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Therapy Services, University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital Birmingham
    • Mr.  Dr.  David  McWilliams 
    • Mindelsohn Way
    • B 152 WB  Birmingham
    • United Kingdom
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    • Universitätsklinikum Schleswig-Holstein, Pflegeforschung, Campus Kiel
    • Mr.  Peter  Nydahl 
    • Brunswiker Str. 10
    • 24105  Kiel
    • Germany
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    • Universitätsklinikum Schleswig-Holstein, Pflegeforschung, Campus Kiel
    • Mr.  Peter  Nydahl 
    • Brunswiker Str. 10
    • 24105  Kiel
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Interdisziplinäre Vereinigung für Intensiv- und Notfallmedizin. e.V.
    • Mr.  Volker  Parvu 
    • Luisenstr. 45
    • 10117  Berlin
    • Germany
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    • PR Manager Health Systems / Corporate Social Responsibility (CSR)Brand, Communications, Digital & MarketingPhilips GmbH Market DACH
    • Ms.  Anke  Ellingen 
    • Röntgenstraße 22
    • 22335  Hamburg
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.